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Generated: April 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 020883

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NDA 020883 describes ARGATROBAN, which is a drug marketed by Amneal Pharms Co, Fresenius Kabi Usa, Hikma Pharm Co Ltd, Hospira Inc, Mylan Institutional, Novartis Pharms Corp, Par Sterile Products, Teva Pharms Usa, Sandoz, Eagle Pharms, and Gland Pharma Ltd, and is included in twelve NDAs. It is available from eight suppliers. There are two patents protecting this drug and two Paragraph IV challenges. Additional details are available on the ARGATROBAN profile page.

The generic ingredient in ARGATROBAN is argatroban. There are eleven drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the argatroban profile page.

Summary for 020883

Tradename:	ARGATROBAN
Applicant:	Novartis Pharms Corp
Ingredient:	argatroban
Patents:	0
Formulation / Manufacturing:	see details

Pharmacology for NDA: 020883

Mechanism of Action	Thrombin Inhibitors

Suppliers and Packaging for NDA: 020883

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ARGATROBAN	argatroban	INJECTABLE;INJECTION	020883	NDA	GlaxoSmithKline LLC	0007-4407	N	0007-4407-01
ARGATROBAN	argatroban	INJECTABLE;INJECTION	020883	NDA	Novartis Pharmaceuticals Corporation	0078-0930	N	0078-0930-61

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	250MG/2.5ML (100MG/ML)
Approval Date:	Jun 30, 2000	TE:	AP	RLD:	Yes

Expired US Patents for NDA 020883

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis Pharms Corp	ARGATROBAN	argatroban	INJECTABLE;INJECTION	020883-001	Jun 30, 2000	➤ Sign Up	➤ Sign Up
Novartis Pharms Corp	ARGATROBAN	argatroban	INJECTABLE;INJECTION	020883-001	Jun 30, 2000	➤ Sign Up	➤ Sign Up
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration

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